Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696617
• Other study ID #: 031-KOC-1108i
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2012
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.

The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.

Description:

Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age : 18-65

• Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks

• MADRS total score of 18 or higher

• Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration

• Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30
• 60mg/d) or venlafaxine ER(150-225mg/d)

Exclusion Criteria:

• Past history of hypersensitivity to aripiprazole

• Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia

• Clinically significant current Axis II (DSM-IV-TR) diagnosis

• A significant risk of suicide corroborated by a score of =5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator

• Pregnancy or in breast-feeding

• Presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function

• Patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics

• Patients with past treatment failures of aripiprazole

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Aripiprazole 6-week group

• Aripiprazole 8-week group

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hamilton Rating Scale for Depression	change of Hamilton Rating Scale for Depression	Change from Baseline at 8 weeks
Other	Clinical Global Impression-severity, Clinical Global Impression-Improvement	change of Clinical Global Impression-severity, Clinical Global Impression-Improvement	Change from Baseline at 8 weeks
Other	Beck Depression Inventory	change of Beck Depression Inventory	Change from Baseline at 8 weeks
Other	Inventory of Depressive Symptomatology Self-Report Scale	change of Inventory of Depressive Symptomatology Self-Report Scale	Change from Baseline at 8 weeks
Other	Drug - Induced Extrapyramidal Symptoms Scale	change of Drug - Induced Extrapyramidal Symptoms Scale	Change from Baseline at 8 weeks
Other	The Liverpool University Neuroleptic Side Effect Rating Scale	change of The Liverpool University Neuroleptic Side Effect Rating Scale	Change from Baseline at 8 weeks
Other	Short From-36 Health survey	change of Short From-36 Health survey	Change from Baseline at 8 weeks
Primary	Quality of Life Scale (QOLS)	change of Quality of Life Scale (QOLS)	Change from Baseline at 8 weeks
Secondary	Montgomery-Åsberg Depression Rating Scale	change of Montgomery-Åsberg Depression Rating Scale	Change from Baseline at 8 weeks